PolyPid Provides Corporate Update and Reports Third Quarter 2024 Financial Results
PolyPid provided updates on its SHIELD II Phase 3 trial of D-PLEX100 for preventing abdominal colorectal surgical site infections. Over 540 patients are enrolled, with the last patient required for the planned unblinded interim analysis now completed. The analysis, expected this quarter, will determine trial continuation or conclusion. Trial enrollment completion of up to 630 patients is expected in December 2024, with top-line results in Q1 2025.
Financial results show R&D expenses of $6.0 million in Q3 2024, up from $3.8 million in Q3 2023. Net loss was $7.8 million ($1.22 per share) compared to $5.6 million ($3.40 per share) in Q3 2023. Cash position stands at $9.5 million, expected to fund operations into Q1 2025.
PolyPid ha fornito aggiornamenti sul suo studio clinico SHIELD II di Fase 3 riguardante D-PLEX100 per prevenire infezioni del sito chirurgico addominale in seguito a interventi di colon rettale. Sono stati arruolati oltre 540 pazienti, e l'ultimo paziente necessario per l'analisi intermedia in cieco programmata è ora completato. L'analisi, prevista per questo trimestre, determinerà se continuare o concludere lo studio. Si prevede il completamento dell'arruolamento dello studio fino a 630 pazienti entro dicembre 2024, con risultati preliminari attesi nel primo trimestre del 2025.
I risultati finanziari mostrano spese per R&S di 6,0 milioni di dollari nel terzo trimestre del 2024, in aumento rispetto ai 3,8 milioni di dollari del terzo trimestre del 2023. La perdita netta è stata di 7,8 milioni di dollari (1,22 dollari per azione) rispetto ai 5,6 milioni di dollari (3,40 dollari per azione) nel terzo trimestre del 2023. La posizione di cassa è di 9,5 milioni di dollari, che si prevede finanzii le operazioni fino al primo trimestre del 2025.
PolyPid proporcionó actualizaciones sobre su ensayo clínico SHIELD II de Fase 3 de D-PLEX100 para prevenir infecciones en el sitio quirúrgico abdominal en cirugías de colon y recto. Se han inscrito más de 540 pacientes, y el último paciente requerido para el análisis intermedio no ciego programado ya se ha completado. El análisis, que se espera este trimestre, determinará si el ensayo continúa o concluye. Se espera que el completamiento de la inscripción del ensayo de hasta 630 pacientes se realice en diciembre de 2024, con resultados preliminares en el primer trimestre de 2025.
Los resultados financieros muestran gastos de I+D de 6.0 millones de dólares en el tercer trimestre de 2024, un aumento respecto a los 3.8 millones de dólares en el tercer trimestre de 2023. La pérdida neta fue de 7.8 millones de dólares (1.22 dólares por acción) en comparación con 5.6 millones de dólares (3.40 dólares por acción) en el tercer trimestre de 2023. La posición de efectivo se sitúa en 9.5 millones de dólares, que se espera financie las operaciones hasta el primer trimestre de 2025.
PolyPid는 D-PLEX100의 SHIELD II 3상 시험에 대한 업데이트를 제공했습니다. 이는 복부 대장 수술 부위 감염 예방을 위한 것입니다. 현재 540명 이상의 환자가 등록되어 있으며, 예정된 비블라인드 중간 분석을 위한 마지막 환자가 완료되었습니다. 이번 분기 중 분석이 이루어질 예정이며, 이는 시험의 지속 여부를 결정할 것입니다. 시험 등록 완료는 2024년 12월까지 최대 630명의 환자로 기대되고 있으며, 주요 결과는 2025년 1분기에 발표될 예정입니다.
재무 결과는 2024년 3분기 R&D 비용이 600만 달러로, 2023년 3분기의 380만 달러에서 증가했음을 보여줍니다. 순손실은 780만 달러(주당 1.22 달러)로, 2023년 3분기의 560만 달러(주당 3.40 달러)와 비교됩니다. 현금 보유액은 950만 달러로, 2025년 1분기까지 운영 자금을 지원할 것으로 예상됩니다.
PolyPid a fourni des mises à jour sur son essai clinique SHIELD II en Phase 3 concernant D-PLEX100 pour prévenir les infections du site chirurgical abdominal liées aux interventions coloproctologiques. Plus de 540 patients sont inscrits, et le dernier patient requis pour l'analyse intermédiaire non aveugle prévue est maintenant complété. L'analyse, attendue ce trimestre, déterminera si l'essai se poursuit ou se termine. La complétion de l'inscription à l'essai jusqu'à 630 patients est prévue pour décembre 2024, avec des résultats préliminaires attendus au premier trimestre 2025.
Les résultats financiers montrent des dépenses en R&D de 6,0 millions de dollars au troisième trimestre 2024, en hausse par rapport à 3,8 millions de dollars au troisième trimestre 2023. La perte nette s'est élevée à 7,8 millions de dollars (1,22 dollar par action) par rapport à 5,6 millions de dollars (3,40 dollars par action) au troisième trimestre 2023. La position de trésorerie est de 9,5 millions de dollars, ce qui devrait financer les opérations jusqu'au premier trimestre 2025.
PolyPid hat Updates zu seiner SHIELD II Phase 3 Studie zu D-PLEX100 zur Verhinderung von chirurgischen Infektionen im Bauchraum nach kolorektalen Eingriffen bereitgestellt. Über 540 Patienten sind eingeschrieben, und der letzte für die geplante unblinde Zwischenanalyse benötigte Patient ist nun abgeschlossen. Die Analyse, die in diesem Quartal erwartet wird, wird die Fortführung oder den Abschluss der Studie bestimmen. Der Abschluss der Einschreibung der Studie von bis zu 630 Patienten wird für Dezember 2024 erwartet, wobei die aktualisierten Ergebnisse im ersten Quartal 2025 veröffentlicht werden sollen.
Die finanziellen Ergebnisse zeigen F&E-Ausgaben von 6,0 Millionen Dollar im 3. Quartal 2024, ein Anstieg von 3,8 Millionen Dollar im 3. Quartal 2023. Der Nettoverlust betrug 7,8 Millionen Dollar (1,22 Dollar pro Aktie) im Vergleich zu 5,6 Millionen Dollar (3,40 Dollar pro Aktie) im 3. Quartal 2023. Die Zahlungsmittelposition beträgt 9,5 Millionen Dollar, die voraussichtlich die Betriebe bis ins 1. Quartal 2025 finanzieren wird.
- Phase 3 SHIELD I trial showed statistically significant reduction in surgical site infections for patients with large surgical incisions
- Accelerated patient enrollment with all 60 planned centers now operational
- Cash position improved to $9.5 million from $5.3 million in December 2023
- Potential funding extension into 2026 if all warrants are exercised
- Increased net loss to $7.8 million in Q3 2024 from $5.6 million in Q3 2023
- R&D expenses increased to $6.0 million from $3.8 million year-over-year
- Current cash runway only extends into Q1 2025 without warrant exercise
Insights
PolyPid's Q3 2024 results show significant financial developments.
The
The SHIELD II trial's progress is particularly noteworthy, focusing on large surgical incisions following encouraging SHIELD I results. The previous trial demonstrated a statistically significant
The expansion to 60 centers across multiple countries and accelerated enrollment indicates strong operational execution. The trial's focus on abdominal colorectal SSIs addresses a significant medical need, with D-PLEX100's efficacy data suggesting potential market disruption in surgical infection prevention.
Last Patient Enrolled for Planned Unblinded Interim Analysis in Ongoing SHIELD II Phase 3 Trial of D-PLEX100
Unblinded Interim Analysis Outcome Expected Later this Quarter
SHIELD II Enrollment Completion Expected in December 2024 with Top-Line Results Anticipated in First Quarter of 2025
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Nov. 13, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2024.
Recent Corporate Highlights:
- Over 540 patients have been enrolled to date in the ongoing SHIELD II Phase 3 trial of D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs).
- Recently enrolled the last patient required (430 subjects) to conduct the planned unblinded interim analysis, which will occur during the current quarter, now that the 30-day follow-up assessment for the last patient has been completed. The unblinded interim analysis will lead to one of the following outcomes: early trial conclusion due to positive efficacy, continuation to planned patient recruitment (up to 630 subjects), sample size re-assessment, or futility.
- Approximately 60 centers are currently open in multiple countries, including in Eastern Europe, the U.S., Germany, Ireland, Portugal and Israel.
- Enrollment completion of up to 630 patients is expected in December 2024 and top-line results anticipated in the first quarter of 2025.
- Recently enrolled the last patient required (430 subjects) to conduct the planned unblinded interim analysis, which will occur during the current quarter, now that the 30-day follow-up assessment for the last patient has been completed. The unblinded interim analysis will lead to one of the following outcomes: early trial conclusion due to positive efficacy, continuation to planned patient recruitment (up to 630 subjects), sample size re-assessment, or futility.
- Results from the Phase 3 SHIELD I trial, one of the largest Phase 3 studies in the prevention of SSIs in colorectal resection conducted in over a decade, were published in the International Journal of Surgery; manuscript available here. Key results:
- A statistically significant reduction of the primary endpoint (a composite of incisional SSI, incisional reinterventions due to poor wound healing, or all-cause mortality) was observed in D-PLEX100 treated patients in a pre-specified analysis of the subpopulation with large surgical incisions (greater than 20 cm; p=0.0032).
- Analysis of the key secondary efficacy outcome, incisional SSI, also indicated a
54.6% reduction in the large surgical incision subgroup (4.4% in D-PLEX100 vs.9.7% in standard of care (SoC), p= 0.0410). - Based on the statistically significant reduction of the primary endpoint in the prespecified subgroup demonstrated in SHIELD I, and following the FDA guidance, the ongoing Phase 3 SHIELD II study focuses on patients with large surgical incisions.
- A statistically significant reduction of the primary endpoint (a composite of incisional SSI, incisional reinterventions due to poor wound healing, or all-cause mortality) was observed in D-PLEX100 treated patients in a pre-specified analysis of the subpopulation with large surgical incisions (greater than 20 cm; p=0.0032).
“We are very encouraged by the recent significant acceleration in patient enrollment due to the opening of all 60 planned centers in the study and the increase in the volume of surgical procedures following the conclusion of the slower summer months,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “With more than 540 patients enrolled to date in SHIELD II, we look forward to the upcoming interim analysis later this quarter. Importantly, we are funded beyond this key data catalyst and, if all the warrants issued in both of our most recent private placement financings are exercised, we would be funded into 2026.”
Financial results for three months ended September 30, 2024
- Research and development (R&D) expenses for the three months ended September 30, 2024, were
$6.0 million , compared to$3.8 million in the same three-month period of 2023. The increase in R&D expenses was driven by the ramp up in patient enrollment in the SHIELD II Phase 3 trial. - General and administrative (G&A) expenses for the three months ended September 30, 2024, were
$1.2 million , similar to the same period of 2023. - Marketing and business development expenses for the three months ended September 30, 2024, were
$0.2 million , compared to$0.3 million for the same period of 2023. - For the three months ended September 30, 2024, the Company had a net loss of
$7.8 million , or ($1.22) per share, compared to a net loss of$5.6 million , or ($3.40) per share, in the three-month period ended September 30, 2023.
Financial results for nine months ended September 30, 2024
- R&D expenses, net for the nine months ended September 30, 2024, were
$15.8 million , compared to$11.6 million for the same nine-month period of 2023. The increase in R&D expenses was driven by the ramp up in patient enrollment in the SHIELD II Phase 3 trial. - G&A expenses for the nine months ended September 30, 2024, were
$3.3 million , compared to$4.3 million for the same period of 2023. - Marketing and business development expenses for the nine months ended September 30, 2024, were
$0.7 million , compared to$1.0 million for the same period of 2023. - The decreases in G&A and marketing and business development expenses were primarily due to the Company’s ongoing cost savings initiatives.
- For the nine months ended September 30, 2024, the Company had a net loss of
$20.5 million , or ($3.82) per share, compared to a net loss of$17.5 million , or ($13.59) per share, in the nine-month period ended September 30, 2023.
Balance Sheet Highlights
- As of September 30, 2024, the Company had cash, cash equivalents, and short-term deposits in the amount of
$9.5 million , compared to$5.3 million on December 31, 2023. PolyPid expects that its current cash balance will be sufficient to fund operations into the first quarter of 2025. If all warrants issued in both of the Company’s most recent private placement financings are exercised, the Company would be funded into 2026.
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, November 13, 2024 | |
| Time: | 8:30 AM Eastern Time | |
| Conference Call: | https://register.vevent.com/register/BI198de55d5c06495994d35cbb213655eb | |
| Webcast: | https://edge.media-server.com/mmc/p/j6bnvt8c |
About SHIELD II
SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (“SoC”), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (“SSI”) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.
About D-PLEX100
D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected enrollment pace, the expected timing for top-line results from the SHIELD II trial and of the unblinded interim analysis, the Company’s expected cash runway and that if all warrants issued in both of Company’s most recent private placement financings are exercised, the Company would be funded into 2026. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on March 6, 2024. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.
References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.
Contacts:
PolyPid Ltd.
Ori Warshavsky
COO – US
908-858-5995
IR@Polypid.com
Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
BRitchie@lifesciadvisors.com
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| U.S. dollars in thousands | ||||||
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Unaudited | Audited | |||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 4,804 | $ | 5,309 | ||
| Restricted deposits | 165 | 300 | ||||
| Short-term bank deposits | 4,728 | - | ||||
| Prepaid expenses and other current assets | 750 | 458 | ||||
| Total current assets | 10,447 | 6,067 | ||||
| LONG-TERM ASSETS: | ||||||
| Property and equipment, net | 6,414 | 7,621 | ||||
| Operating lease right-of-use assets | 2,464 | 1,597 | ||||
| Other long-term assets | 269 | 87 | ||||
| Total long-term assets | 9,147 | 9,305 | ||||
| Total assets | $ | 19,594 | $ | 15,372 | ||
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| U.S. dollars in thousands (except share and per share data) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 5,178 | $ | 4,003 | ||||
| Accrued expenses and other current liabilities | 2,770 | 1,971 | ||||||
| Trade payables | 1,641 | 772 | ||||||
| Current maturities of operating lease liabilities | 888 | 540 | ||||||
| Total current liabilities | 10,477 | 7,286 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 2,529 | 6,379 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,421 | 857 | ||||||
| Other liabilities | 461 | 398 | ||||||
| Total long-term liabilities | 6,959 | 10,182 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares with no par value - | ||||||||
| Authorized: 107,800,000 and 107,800,000 shares at September 30, 2024 (unaudited) and | ||||||||
| December 31, 2023, respectively; Issued and outstanding: 6,803,478 and 1,653,559 shares at September 30, 2024 (unaudited) and December 31, 2023, respectively. | - | - | ||||||
| Additional paid-in capital | 260,969 | 236,213 | ||||||
| Accumulated deficit | (258,811 | ) | (238,309 | ) | ||||
| Total shareholders' equity (deficit) | 2,158 | (2,096 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 19,594 | $ | 15,372 | ||||
| INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||
| U.S. dollars in thousands (except share and per share data) | ||||||||||||
| Nine Months Ended | Three Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development, net | $ | 15,784 | $ | 11,560 | $ | 5,974 | $ | 3,806 | ||||
| Marketing and business development | 747 | 1,003 | 246 | 261 | ||||||||
| General and administrative | 3,277 | 4,305 | 1,166 | 1,193 | ||||||||
| Operating loss | 19,808 | 16,868 | 7,386 | 5,260 | ||||||||
| Financial expense, net | 665 | 581 | 354 | 319 | ||||||||
| Loss before income tax | 20,473 | 17,449 | 7,740 | 5,579 | ||||||||
| Income tax expenses | 29 | 60 | 20 | 25 | ||||||||
| Net loss | $ | 20,502 | $ | 17,509 | $ | 7,760 | $ | 5,604 | ||||
| Basic and diluted loss per ordinary share | $ | 3.82 | $ | 13.59 | $ | 1.22 | $ | 3.40 | ||||
| Weighted average number of ordinary | ||||||||||||
| shares used in computing basic and | ||||||||||||
| diluted loss per share | 5,362,858 | 1,288,678 | 6,361,286 | 1,650,259 | ||||||||
FAQ
What are the key results from PolyPid's (PYPD) SHIELD II Phase 3 trial enrollment?
What were PolyPid's (PYPD) Q3 2024 financial results?
What were the SHIELD I trial results for PolyPid's (PYPD) D-PLEX100?
